Spectrum Pharmaceuticals announced that data from the Phase 3 RECOVER clinical study was presented during the 2018 San Antonio Breast Cancer Symposium. These data confirm the efficacy and safety of ROLONTIS in reducing the Duration of Severe Neutropenia in breast cancer patients treated with chemotherapy. ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor being studied as a treatment for neutropenia in patients undergoing treatment with myelosuppressive cytotoxic chemotherapy. The data released yesterday in a poster presentation from the ROLONTIS Phase 3 RECOVER study showed that in Cycle 1, the mean DSN+/-SD was 0.31+/-0.688 days for ROLONTIS and 0.39+/-0.949 days for pegfilgrastim, demonstrating non-inferiority. The non-inferiority of ROLONTIS for DSN was maintained across all four treatment cycles. Incidence of severe neutropenia was 20 percent versus 24 percent in the eflapegrastim and pegfilgrastim arms respectively, with a relative risk reduction of 14 percent in favor of eflapegrastim. There were no statistically significant differences on secondary endpoints such as time to absolute neutrophil count recovery, depth of ANC nadir, and incidence of febrile neutropenia between treatment arms across all cycles. None of the greater than or equal to Grade 3 study drug related adverse events occurred in greater than 2% of the patients and included hematologic and bone pain related AEs in both arms. The RECOVER trial is the second ROLONTIS Phase 3 study to meet the primary efficacy endpoint of non-inferiority in mean DSN. Results from ADVANCE, the first ROLONTIS Phase 3 study, were announced at the 2018 American Society of Clinical Oncology Annual Meeting and presented at the Multinational Association in Supportive Care in Cancer Annual Meeting earlier this year.

Spectrum Pharmaceuticals announced results from a prospective Phase 2 single-arm, open-label, multicenter clinical trial studying the management of oral mucositis with the use of oral leucovorin as adjunct to FOLOTYN in patients with hematological malignancies, including PTCL and CTCL. Study results with a total of 35 patients demonstrated that use of leucovorin 25 mg tablets by oral administration for two days, initiated 24 hours after each FOLOTYN dose reduced the rate of Grade 2 or greater mucositis significantly, to 5.7 percent from historic rate associated with FOLOTYN use. There were no reports of greater than or equal to Grade 3 oral mucositis. Grade 1 oral mucositis was reported only in 4 patients. No patient omitted, delayed or reduced FOLOTYN dose due to oral mucositis with adjunct leucovorin therapy. The occurrence of mucositis, an impediment of FOLOTYN, has previously been reported at a rate of 52 percent at Grade 2 or higher in patients undergoing treatment with FOLOTYN in a registration study.

Spectrum price target lowered to $29 from $35 at B. Riley FBR. B. Riley FBR analyst David Buck lowered his price target for Spectrum Pharmaceuticals to $29 to reflect "some more conservatism" given the recent weakness in the group and passing of some expected catalysts. Poziotinib remains the key pipeline focus, with the company filing for breakthrough therapy confirmed with its Q3 results, Buck tells investors in a research note. He keeps a Buy rating on Spectrum.